510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913543Substantially Equivalent

Thoracic Catheter Stylet

Intl. Medical Devices, Ltd., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913543 is the FDA 510(k) clearance record for THORACIC CATHETER STYLET, a class II device, cleared for Intl. Medical Devices , Ltd. on under FDA product code DRB (Stylet, Catheter). FDA records list 12 510(k) clearances for Intl. Medical Devices , Ltd., from to . As of , FDA records show no recalls naming K913543.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Intl. Medical Devices , Ltd. 11845 W. Olympic Blvd., Los Angeles CA
510(k) summary
Statement
Third party review
No

Clearances, product code DRB

Trailing 12 months

FDA records hold no clearances under product code DRB in the trailing twelve months.

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260